Published online Nov 2, 2016. doi: 10.5314/wjd.v5.i4.129
Peer-review started: June 14, 2016
First decision: July 29, 2016
Revised: August 22, 2016
Accepted: October 1, 2016
Article in press: October 9, 2016
Published online: November 2, 2016
To evaluate the safety and efficacy of Viora’s new multi-polar radiofrequency (RF) handpiece.
A group of twelve volunteers (11 females and 1 male) participated in the current study, ranging in age from 23-70 years with Fitzpatrick skin type II-V. The inclusion criteria for the enrollment were no contraindications for the treatment, body mass index (BMI) < 35 and local fat accumulation or cellulite formation. A total of 19 treatment areas were treated in the study: 9 abdomen, 2 abdomen plus flanks, 2 arms and 6 thighs. The treatment performed with new multi-polar RF handpiece (V-FORM) with 4 levels of RF power (up to 50 W), 4 levels of vacuum pressure intensity (up to 500 mbar) and 4 operational modes (0.8, 1.7 and 2.45 MHz). Circumferential reduction and cellulite reduction treatments were performed once a week (7 ± 1 d) for a treatment series of 3-8 sessions. The clinical assessment of the treatment outcomes included skin moisture level, skin impedance, body temperature, circumferential measurements, clinical photographic assessment and BMI.
Ten of twelve patients completed the treatment course. No side effects were recorded during the study. The skin responded with slight erythema and sometimes edema, which is considered a positive end-point. All patients maintained a stable weight during the entire period of the study. No patient underwent any treatments or took medications for fat volume reduction during the study. A moderate positive correlation was found between the patient’s age and BMI (correlation coefficient 0.54). The initial body temperature increased in average to 34.0 °C from 31.9 °C, the initial skin moisture level increased to an average 40.98% from 38.9% and the initial skin impedance decreased by 3.8%-35.9% by the end of the treatment course. The pre-heating time for all body areas ranged between 1-6 min with negative correlation to the body’s end-point temperature (correlation coefficient -0.31). All patients responded to the treatment and showed some degree of circumferential reduction (up to 15 cm), on at least one of two-three measured points.
According to clinical data collected in this study, the new V-FORM handpiece represents an effective treatment with 100% response rate, with the safest treatment profile.
Core tip: The significant change in circumferential measurements post-V-FORM treatments can be contributed not only to volume reduction due to improved metabolic rate and enhanced natural lipolysis, but also to edema reduction due to vacuum pressure integrated in the handpiece. Moreover, this technology enables the control of radiofrequency depth penetration which allows finishing the treatments with a skin tightening effect using higher radiofrequency frequencies (1.7 and 2.45 MHz).